Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument
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|ClinicalTrials.gov Identifier: NCT04525651|
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : September 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cervical Spondylosis||Device: Digital Acupuncture Manipulation Therapeutic Instrument Other: Manual Acupuncture Other: Sham Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument|
|Actual Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Digital Acupuncture Instrument Group
The needles will be stimulated manually to achieve de qi (a compositional sensation including soreness, numbness, distention and heaviness) and then paired electrodes from the digital acupuncture instrument will be attached to the needle handles and another two adjunct acupoints by the research assistant. The electric current will be increased until the needles begin to vibrate slightly.
Device: Digital Acupuncture Manipulation Therapeutic Instrument
The device is based on the characteristics of traditional acupuncture manipulation of Shanghai School of Traditional Chinese Medicine, and absorbs the information of the techniques of famous experts, modulates the stimulation waveform of the electroacupuncture device by modulating the signal, and realizes the digitization of acupuncture technique information.
Active Comparator: Manual Acupuncture Group
Patients in the MA group will undergo similar procedures as the EA group except that no current will be output from the instrument.
Other: Manual Acupuncture
Manual acupuncture to acheive de qi.
Sham Comparator: Sham Acupuncture Group
Patients in the SA group will receive non-invasive acupuncture to avoid de qi.
Other: Sham Acupuncture
Sham acupuncture to avoid de qi.
- Visual Analogue scale（VAS） [ Time Frame: Change from baseline VAS at 4weeks ]A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.
- Visual Analogue scale（VAS） [ Time Frame: Change from baseline VAS at 8weeks ]A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.
- Neck Disability Index（NDI） [ Time Frame: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8) ]A scale that helps a patient to quantify neck disability.
- short form 36-item questionnaire, SF-36 [ Time Frame: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8) ]a set of 36 questions abstracted from the much longer set of several hundred used in household interview surveys of the U.S. National Health Survey. The SF36 questions are a convenient abbreviation, used for screening purposes to assess the physical function, social function, role limitation, mental health, energy, vitality, pain, and subjective perception of health status. They have been tested and found to be valid and reliable.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525651
|Contact: Jian Pei, Doctor||00862164385700 ext firstname.lastname@example.org|
|LongHua Hospital Shanghai University of Traditional Chinese Medicine||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Jian Pei, Doctor 00862164385700 ext 3534 email@example.com|
|Study Chair:||Jian Pei, Doctor||Shanghai University of Traditional Chinese Medicine|